Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344117
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-27
Brief Title:
Assessment of Volatile Organic Compounds VOC for the Diagnosis of Invasive Aspergillosis IA in Lung Transplant Recipients
Sponsor:
Owlstone Ltd
Organization:
Owlstone Ltd
Study Overview
Official Title:
Assessment of Volatile Organic Compounds VOC for the Diagnosis of Invasive Aspergillosis IA in Lung Transplant Recipients A Prospective Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UHN
Brief Summary:
Prospective observational pilot study to evaluate the utility of breath VOCs to detect invasive aspergillosis in lung transplant recipients that are suspected of invasive fungal disease IFD
Detailed Description:
Invasive aspergillosis IA remains a major cause of morbidity and mortality in immunosuppressed patients The diagnosis of IA is challenging due to lack of sensitive and specific clinical and radiological signs and tissue biopsy is often precluded in many patients Culture and microscopy of respiratory tract samples are relatively insensitive diagnostic tests Early detection of IA can lead to specific therapeutic strategies and improved patient outcomes Breath is a rich and complex sampling medium containing both volatile organic compounds VOCs and respiratory droplets carrying non-volatiles proteins lipids viruses and even bacteria The major advantage of exhaled breath analysis is non-invasiveness with existing sampling methods already readily available
The diagnostic or prognostic value of exhaled breath analysis has been evaluated in many respiratory diseases including asthma Chronic Obstructive Pulmonary Disease idiopathic pulmonary fibrosis as well as in some lung infections such as bacterial pneumonia In the particular field of aspergillosis diagnosis using a chromatographic-mass spectrometry analysis of exhaled breath in immunocompromised hosts organ transplantation hematological malignancies or HSCT researchers have been able to identify an exhaled breath metabolic signature made of β-trans-bergamotene α-trans-bergamotene a β-vatirenene-like sesquiterpene and trans-geranylacetone that potentially allows the discrimination of probable or proven aspergillosis from other lung infections with high levels of sensitivity and specificity Exhaled breath therefore appears as a promising field for the improvement of IA diagnosis and more broadly of respiratory infections Volatile organic compound VOC detection via thermal desorptiongas chromatography-mass spectrometry has emerged as a promising tool for early diagnosis of IA however the sample sizes have been limited As such the proposed pilot study aims to identify potential VOC biomarkers for both IA and Aspergillus colonization and assess the feasibility of VOCs on breath for the diagnosis of IA in lung transplant recipients
The diagnostic or prognostic value of exhaled breath analysis has been evaluated in many respiratory diseases including asthma Chronic Obstructive Pulmonary Disease idiopathic pulmonary fibrosis as well as in some lung infections such as bacterial pneumonia In the particular field of aspergillosis diagnosis using a chromatographic-mass spectrometry analysis of exhaled breath in immunocompromised hosts organ transplantation hematological malignancies or HSCT researchers have been able to identify an exhaled breath metabolic signature made of β-trans-bergamotene α-trans-bergamotene a β-vatirenene-like sesquiterpene and trans-geranylacetone that potentially allows the discrimination of probable or proven aspergillosis from other lung infections with high levels of sensitivity and specificity Exhaled breath therefore appears as a promising field for the improvement of IA diagnosis and more broadly of respiratory infections Volatile organic compound VOC detection via thermal desorptiongas chromatography-mass spectrometry has emerged as a promising tool for early diagnosis of IA however the sample sizes have been limited As such the proposed pilot study aims to identify potential VOC biomarkers for both IA and Aspergillus colonization and assess the feasibility of VOCs on breath for the diagnosis of IA in lung transplant recipients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None